Via Alex Butler
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Pharma Industry Regulation
Stories & Insights Regarding Marketing Regulations & Guidelines
Curated by Pharma Guy
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Innovation in medicine is getting faster while the processes the US Food and Drug Administration (FDA) uses are sometimes decades old. The Patient Engagement Advisory Committee, launched in September 2015, was a great step forward. But regulators are unprepared for some big changes on the horizon.
Here are the top five issues that I believe will shape the future of the regulatory environment.
1) Patients taking action
If regulations don’t support the trends and technologies that make lives better, patients will take action themselves.
2) The ‘Uberification’ of healthcare
The FDA will have to be at its best to prevent this. And it must hurry up – The Heal app and Go2Nurse in Chicago have already started this disruption around how healthcare is delivered.
So far, the FDA has not been keen on regulating the wearable market heavily. But when such disruptive technologies hit the market, it will be years behind.
The progress of technology cannot be stopped. Similarly, we all want healthcare to be safe, affordable and efficient. However, to regulate these disruptive trends without stifling innovation, the FDA must have the clearest vision and the best knowledge about healthcare trends.
The biggest challenge today is that the regulators are not at the forefront of innovation and they cannot hope to anticipate and regulate changes that they don’t yet understand.